An optimal adaptive design to address local regulations in global clinical trials.

After multi-regional clinical trials (MRCTs) have demonstrated overall significant effects, evaluation for a region-specific effect is often important. Recent guidance from regulatory authorities regarding evaluation for possible country-specific effects has led to research on statistical designs that incorporate such evaluations in MRCTs. These statistical designs are intended to use the MRCTs to address the requirements for global registration of a medicinal product.